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Targeting Right Ventricle in Pulmonary Hypertension Gilead

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02829034
Recruitment Status : Completed
First Posted : July 12, 2016
Results First Posted : February 26, 2019
Last Update Posted : February 26, 2019
Sponsor:
Collaborators:
Brigham and Women's Hospital
University of Maryland
Gilead Sciences
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief Summary:
This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their health by improving right ventricular (RV) function.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Drug: Ranolazine Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Using Cardiovascular MRI
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Ranolazine
Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day
 Drug: Ranolazine
Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks.
Other Name: Ranexa
Placebo Comparator: Placebo
Placebo by mouth twice per day
 Drug: Placebo
Placebo by mouth twice per day for a total of 26 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage) [ Time Frame: 26 weeks ]
    Change in right ventricle ejection fraction as assessed by MRI


Secondary Outcome Measures :
  1. Percent Change in 6min-walk-test Distance [ Time Frame: 6 months ]
    6-minute walk test

  2. Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) [ Time Frame: 6 months ]
    NT-proBNP measured at 6-months compared to baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic pulmonary hypertension based on one of the following criteria:

    • Idiopathic pulmonary arterial hypertension
    • Familial pulmonary arterial hypertension
    • Pulmonary hypertension associated with connective tissue disease
    • Chronic thromboembolic pulmonary hypertension-nonsurgical/distal vessel disease or patients who are reluctant to go to surgery within a 6-month period and are willing to participate
    • Simple congenital such as repaired atrial septal defect or ventricular septal defect or unrepaired small atrial septal defect or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension
    • Group 3 patients who have a component of pulmonary arterial hypertension *Pulmonary hypertension caused by conditions affect the veins and small vessels of the lungs
    • Sickle cell disease
    • Group 5 pulmonary hypertension such as polycythemia vera
    • Essential thrombocythemia
    • Sarcoidosis
    • Vasculitis
    • Metabolic disorder
  • World Health Organization functional class II, III, or IV
  • Mean pulmonary artery pressure >25 mmHg at rest
  • Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg
  • Pulmonary vascular resistance > 3 mmHg/L/min
  • Right ventricle ejection fraction < 45%
  • 6-minute walk test distance > 50 meters

Exclusion Criteria:

  • Previous treatment with or prior sensitivity to ranolazine
  • Any family history of corrected QT interval prolongation, congenital long QT syndrome, or receiving drugs that prolong the corrected QT interval
  • Parenchymal lung disease showing total lung capacity < 50% of predicted OR forced expiratory volume at one second/forced vital capacity < 50%
  • Portal hypertension associated with chronic liver disease
  • Left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, Any left ventricle cardiomyopathy, Left ventricular systolic dysfunction defined as an ejection fraction < 50%, Symptomatic coronary artery disease
  • Uncontrolled systemic hypertension
  • Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829034


Locations
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United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Brigham and Women's Hospital
University of Maryland
Gilead Sciences
Investigators
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Principal Investigator: Yuchi Han, MD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Study Protocol and Statistical Analysis Plan  [PDF] March 9, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02829034    
Other Study ID Numbers: 824808
First Posted: July 12, 2016    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Pennsylvania:
pulmonary hypertension
right ventricular function
ranolazine
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
 Respiratory Tract Diseases
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action